New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

Not Applicable

Recruiting

• Conditions: Macrosomia, Fetal; Gestational Diabetes Mellitus in Pregnancy
• Interventions: Diagnostic Test: Pregnant women

• Registration Number: NCT06048510
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Gestational diabetes mellitus (GDM) increases the risk of macrosomia and other adverse pregnancy outcomes. Screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. The objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to HbA1c (reference) as predictors of GDM, macrosomia and other adverse outcomes, in pregnant women.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Status Verified: 2023-12
• Study Start: 2023-12-18
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	Pregnant women	Pregnant women, with gestational age at inclusion \<28 weeks of amenorrhea, with or without risk factors for GDM will be included in the first consultation at the Maternity Hospital (Bordeaux University Hospital). Determination of glycation markers (HbA1c, glycated albumin, and skin autofluorescence).

Primary Outcome Measures

Name	Time	Method
Incidence of GDM diagnosed during pregnancy.	At trimester 1	The primary outcome is the incidence of GDM diagnosed during pregnancy after inclusion in the trial. The measure is performed by fasting blood glucose:≥ 0.92 g/L and \< 1.26 g/L,or based on the result of the 75g OGTT performed at 24-28 weeks of amenorrhea, if glycemia at time 0 ≥ 92 mg/dL (5.06 mmol/L) and/or time 60min ≥ 180 mg/dL (9.9 mmol/L) and/or time 120min ≥153 mg/dL (8.42 mmol/L).

Secondary Outcome Measures

Name	Time	Method
Neonatal morbidity 3	Between the day of delivery and the following day	Hospitalization in neonatology or neonatal intensive care unit
Neonatal morbidity 2	Between the day of delivery and the following day	Documentation of neonatal morbidity diagnosis
Neonatal morbidity 4	Between the day of delivery and the following day	Presence of anoxic-ischemic encephalopath or neonatal seizure
Fetal morbidity	Between the day of delivery and the following day	Incidence of fetal death in utero
Obstetrical outcome	Between the day of delivery and the following day	Incidence of labor induction, caesarean section, instrumental delivery.
Maternal morbidity	Between the day of delivery and the following day	Documentation of maternal morbidity diagnosis
Neonatal morbidity 1	Between the day of delivery and the following day	Incidence of macrosomia (by birth weight ≥ 4,000g and Large for Gestational Age if ≥ 90th centiles according to sex and gestational age)

Trial Locations

Locations (1)

Hopital Pellegrin; 🇫🇷 Bordeaux, France